Clinical Research Associate II
hace 2 semanas
Job Summary:
Clinical Research Associate II - Experience in Lipids and Cardiovascular
About the Role:
We are seeking a highly skilled Clinical Research Associate II with experience in lipids and cardiovascular to join our team. As a Clinical Research Associate, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
Key Responsibilities:
- Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
- Demonstrates diligence in protecting the confidentiality of each subject/patient.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
- Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
- Reconciles contents of the ISF with the Trial Master File (TMF).
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
- Supports subject/patient recruitment, retention, and awareness strategies.
- Enters data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
Requirements:
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Excellent communication, presentation, and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.
About Syneos Health:
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
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